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Trial Title:
SEQUENTIAL PROFILING OF TUMOR-DERIVED CIRCULATING CELL-FREE DNA (ctDNA) IN ADVANCED OVARIAN CANCER PATIENTS
NCT ID:
NCT06071286
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Blood samples
Description:
Patients with suspected advanced OC, based on preoperative imaging/clinical evaluation,
will undergo blood samples in different timepoints
Arm group label:
Interventional
Summary:
Ovarian cancer (OC) is the third most common gynaecologic cancer worldwide and has the
highest mortality rate among gynaecologic cancers. Despite the advances in cytoreductive
surgery and frontline chemotherapy, recurrence is a common event in the advanced disease
setting, with more than 70% of women experiencing relapse within two years from
diagnosis.
New strategies to anticipate the diagnosis of recurrence have been investigated in the
last years. In this context, standard serum biomarkers, such as CA-125, and radiological
evaluation are commonly used for disease surveillance, However, the early identification
of relapsed disease as well as the identification of patients at higher risk for
recurrence are still unmetclinical needs. Novel and reliable molecular biomarkers, which
might also better represent the intrinsic molecular complexity of OC, could help
clinicians to address this important challenge.
Circulating tumor DNA (ctDNA) analysis has recently emerged as a non-invasive tool to
profile and monitor tumor evolution over time. CtDNA has been extensively studied in
several neoplasms in order to evaluate its ability in anticipating detection of relapse
compared to common markers used in clinical practice. Wehave designed a study to assess
the ability of ctDNA to detect recurrence and progression of disease and to provide a
genomic characterization, during follow-up of patients with advanced OC. If proven
effective and reliable, ctDNA could be introduced into routine surveillance programme for
OC.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Newly diagnosed suspicious International Federation of Gynecology and Obstetrics
(FIGO) stage III A or greater ovarian, fallopian tube, or primary peritoneal cancer
2. Age between 18 and 80 years
3. Estimated life expectancy of at least 4 weeks 4. Signed informed consent
Exclusion Criteria:
1. Any previous cancer in the last 5 years
2. Previous chemotherapy or target treatments 3. Diagnosis of synchronous tumors
3. Pregnancy or breastfeeding
4. Missed informed consent
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Address:
City:
Roma
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Camilla Nero, PHD
Phone:
0630158667
Email:
camilla.nero@policlinicogemelli.it
Start date:
November 1, 2023
Completion date:
November 1, 2025
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06071286
